Transcatheter edge-to-edge repair of the mitral valve (M-TEER) is a well-established endovascular treatment option for patients with severe mitral regurgitation who are at high risk for surgery-related complications. However, the procedure carries a risk of clinically overt strokes and imaging-detected brain lesions, which may potentially be mitigated through the use of cerebral protection devices.
This prospective, multi-center, randomized, controlled study aims to assess the efficacy and safety of cerebral protection device, compared to a control group undergoing unprotected M-TEER.
Age ≥18 years
Severe Mitral Regurgitation (3+ to 4+)
Symptom status: NYHA functional class ≥ II
Subjects scheduled to receive the M-TEER per the current approved indications for use
Contraindication to MRI
CABG, PCI, TAVR, CRT or CRT-D within the prior 30 days
Aortic or tricuspid valve disease requiring surgery or transcatheter intervention
COPD requiring continuous home oxygen therapy or chronic outpatient oral steroid use
Parallel
Cerebral Embolic Protection
DeviceSubjects will undergo M-TEER following placement of the cerebral embolic protection device.
Total amounts of new lesions
Total amounts of new lesions in the brain assessed by diffusion weighted magnetic resonance imaging (DW-MRI) at 72 hours.
Total new lesion volume
Total new lesion volume assessed by diffusion weighted magnetic resonance imaging (DW-MRI) at 72 hours
Incidence of delirium
Incidence of delirium
NIHSS worsening
NIHSS worsening
Incidence of peri- and postprocedural stroke
Incidence of peri- and postprocedural stroke
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Xiao-dong Zhuang
Lead sponsor
Sun Yat-sen University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
